Home based role
ICON is a integral healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

We are currently seeking a Manager, TMF Operations to join our diverse and dynamic team. As a Manager of TMF Operations at ICON, you will oversee the management, maintenance, and compliance of the Trial Master File (TMF) for clinical research studies. You will lead a team responsible for ensuring that all TMF documentation is accurate, complete, and meets regulatory requirements, playing a critical role in supporting the successful execution of clinical trials.
What You Will Be Doing:
- Managing the TMF Operations team responsible for maintaining the Trial Master File (TMF) across multiple clinical studies, ensuring compliance with GCP and regulatory requirements.
- Overseeing the collection, review, and filing of essential documents,



ensuring timely and accurate updates to the TMF throughout the clinical trial lifecycle.
- Collaborating with cross-functional teams, including clinical operations, regulatory affairs, and quality assurance, to ensure TMF completeness and readiness for audits and inspections.
- Developing and implementing TMF management strategies, policies, and procedures to improve efficiency and ensure adherence to industry standards.
- Monitoring TMF quality metrics, identifying areas for improvement, and driving continuous process enhancements.
- Providing leadership and training to TMF staff, fostering a culture of quality and compliance within the team.
- Ensuring readiness of TMF for regulatory audits and client inspections, addressing any findings or gaps in documentation as needed.

Your Profile:
- Bachelor’s degree in life sciences, clinical research, or a related field. Advanced degree or certifi

📌 Manager, TMF Operations (Ciudad de México)
🏢 IRE
📍 Ciudad de México